Frequent monitoring and tight metabolic control of blood glucose levels can reduce microvascular complications and subsequent co-morbidities in patients with diabetes. Self-monitoring with finger sticks provides intermittent data at best, and results in poor compliance. We report on a minimally invasive system that continually measures glucose flux through ultrasonically permeated skin. Ten patients with diabetes were enrolled in a clinical study to determine correlation between data collected by glucose biosensors placed over ultrasonically treated skin sites (two per patient), and blood glucose readings were taken every 20 min over an 8-h period. Glucose flux biosensors measured amperometric current proportional to hydrogen peroxide level, generated from catalytic conversion of glucose by glucose oxidase; the sensor was coupled to the skin by a thin hydrogel containing an osmotic extraction buffer, creating a gradient for glucose transport through the skin. The biosensors were attached to small portable meters that recorded time, current, and temperature readings every 5 s. At the conclusion of the study period, meter recordings were downloaded for data processing. Skin sites were examined for irritation due to biosensor contact. Data from glucose biosensors with completed data sets had a correlation coefficient of 0.84, and 95% of the data pairs (n = 241) were in the A + B region of a Clarke error grid. Ultrasonic pretreatment lasting about 10 s resulted in improved conductance in all patients. No patients complained of pain or irritation at any time during the study. Continuous monitoring of glucose flux through ultrasonically permeable skin is safe and feasible.

Continuous transdermal glucose monitoring was demonstrated successfully in diverse clinical settings. The performance of abrasion was equivalent to ultrasound skin permeation methodology for transdermal glucose monitoring.

BACKGROUND: Ultrasound‐facilitated delivery of topical anesthetics has been used to achieve effective anesthesia within 5 minutes for venipuncture and the insertion of intravenous access devices, but has never been studied for blood donation. STUDY DESIGN AND METHODS: This study was a single‐center, prospective, randomized, sham treatment–controlled, single‐blinded clinical evaluation. Repeat donors were randomly assigned to undergo treatment with ultrasound and topical anesthetic or sham ultrasound and placebo anesthetic before phlebotomy for whole blood donation. The primary outcome measures were pain assessments using the Verbal Categorical Scale (VCS) and the Visual Analogue Scale and the assessment of skin irritation at the target site. RESULTS: One‐hundred subjects were enrolled and all completed the study. Compared to the sham/placebo control group, donors receiving ultrasound/anesthetic had lower pain scores on the VCS (1.81 ± 0.67 vs. 2.17 ± 0.68; p = 0.01) and Visual Analog Scale (17.2 ± 15.5 vs. 27.6 ± 19.5; p = 0.006). The proportion of subjects in the treatment group who experienced skin irritation (8%) was similar to that in the control group (2%; p = 0.20). CONCLUSION: Ultrasound‐enhanced delivery of topical anesthetic was demonstrated to be a safe means of quickly achieving clinically meaningful reduction in the pain of phlebotomy for whole blood donation compared to sham/placebo treatment.